Application 017001

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ANCOBON	FLUCYTOSINE	CAPSULE;ORAL	250MG	Yes	No
002	ANCOBON	FLUCYTOSINE	CAPSULE;ORAL	500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017001-001	ANCOBON	FLUCYTOSINE	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017001-002	ANCOBON	FLUCYTOSINE	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017001-001	AB
N017001-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017001-001	ANCOBON	250MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017001-002	ANCOBON	500MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017001-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017001-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017001-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017001-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017001-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017001-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017001-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017001-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017001-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017001-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017001-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017001-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017001-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017001-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017001-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017001-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017001-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017001-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017001-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017001-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017001-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017001-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017001-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017001-002	AB	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANCOBON	FLUCYTOSINE	Bausch Health US LLC	aea0df00-a88c-4a16-abcf-750f3ff2004e	2022-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017001 application number: NDA017001 ndc (product): 0187-3554 ndc (product): 0187-3555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-3554	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
0187-3554	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
0187-3554	ANCOBON	Flucytosine	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-3554	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
0187-3555	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
0187-3555	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
0187-3555	ANCOBON	Flucytosine	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-3555	ANCOBON	Flucytosine	Bausch Health US LLC	NDA	Current
42494-339	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-339	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-339	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-339	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-340	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-340	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-340	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
42494-340	Flucytosine	Flucytosine	Cameron Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
63629-2147	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2147	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2147	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2148	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2148	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-2148	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-9156	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-9156	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-9157	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-9157	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-9291	Flucytosine	Flucytosine	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70178	SUPPL	2022-02-16
70175	SUPPL	2022-02-16
57609	SUPPL	2019-02-14
57585	SUPPL	2019-02-13
50484	SUPPL	2017-11-25
50365	SUPPL	2017-11-13
49521	SUPPL	2017-08-23
525	SUPPL	2009-05-07
13068	SUPPL	2006-08-11
10947	SUPPL	2006-08-11
13067	SUPPL	2003-05-29
524	SUPPL	2003-05-29
33214	SUPPL	2003-05-06
33213	SUPPL	2003-05-06